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10 articles for “QbD”
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Quality by Design (QbD) Approach for Optimization and Development of Nano Drug Delivery Systems
Abstract: To clearly understand the formulation of high quality pharmaceutical products, FDA generalized quality by design (QbD) in the field of pharmacy, which is based on the thorough understanding of how materials and process parameters affect the quality profile of final products. Quality by design is a risk management and science-based approach promoted by the United States food and drug administration to enhance pharmaceutical development throughout a product’s life cycle. The …
Published in Trends in Drug Delivery · Vol. 3, Issue 3, 2016 · pp. 23–32 Read article
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HPLC Method Development by Using QBD Approach: An Overview
Abstract: HPLC is a critical analytical method for obtaining medicinal product information. The HPLC method should be capable of separating, detecting, and quantifying a variety of medicines and associated compounds. Validation is the process of determining the performance and qualities of a product or service. In this paper, I assembled HPLC data using their QbD method. It is more efficient than traditional HPLC. This is the most versatile, safe, reliable, and …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 13, Issue 1, 2022 · pp. 30–35 Read article
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Implementing Quality by Design (QbD): Strategies, Challenges, and Best Practices across Industries
Abstract: The present comprehensive review investigated the dynamic landscape of quality standards within the pharmaceutical sector, with a primary focus on the implementation and impact of Quality by Design principles. It illuminated the multifaceted challenges encountered by pharmaceutical companies in upholding stringent quality standards amidst evolving regulatory requirements and complex manufacturing processes. By embracing Quality by Design principles, the industry aims to foster a proactive and systematic approach to product development …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 2, 2024 · pp. 28–36 Read article
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Formulation And Evaluation Of Captopril Sustained Release Tablet By Qbd Approach.
Abstract: The purpose of present study was to formulation and evaluation of Captopril sustained release tablet by QbD approach using size expanding polymer and cross linker. Captopril is a ACE inhibitor use in treatment of mild to moderate hypertension. Captopril having biological half-life of 2 hrs. The drugs gets degrade as its goes to higher pH, so we selected size expanding GRDDS. In formulation development study by using QbD, we found …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 10, Issue 1, 2023 · pp. 64–73 Read article
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Innovative strategies in capsule formulation from concept to market
Abstract: Innovative strategies in capsule formulation have revolutionized drug delivery and nutraceutical development, offering advanced solutions from initial concept to market release. This report explores the transformative techniques at each stage of capsule formulation, detailing novel approaches in ingredient selection, encapsulation technology, and manufacturing processes. By leveraging advancements in artificial intelligence, encapsulation methods, such as liposomal and nanoparticle technologies, and materials science, formulators can optimize the bioavailability, stability, and targeted delivery …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 12, Issue 1, 2025 · pp. 1–8 Read article
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Sumatriptan Succinate Mucoadhesive Buccal Tablets: Formulation Design, Optimization and Evaluation
Abstract: The main aim of present investigation was to develop and study mucoadhesive buccal tablets of sumatriptan succinate using different bioadhesive polymer. Nine formulations were prepared by using direct compression method with varying concentration of polymer as HPMC (Metolose SR 90SH-15000), xanthan gum (XTGM) and sodium carboxy methyl cellulose (sodium CMC). Fourier transform infrared spectroscopy was used to identify drug excipient interaction. Micromeritic properties of lubricated blend, physical properties and chemical …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 13, Issue 2, 2022 · pp. 1–20 Read article
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Navigating the Horizon: Current Trends in Elevating Quality Assurance in Clinical Research
Abstract: The landscape of clinical research quality management has evolved significantly in recent years, driven by stringent regulatory frameworks and globalization of trials. This evolution underscores the importance of integrating quality into all aspects of the clinical trial process from design to postresearch activities. Concepts such as Good Clinical Practice (GCP) and Quality by Design (QbD) are central to ensuring the reliability and accuracy of trial data while safeguarding patient safety …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 11, Issue 1, 2024 · pp. 1–8 Read article
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Recent Advances in Quality Control and Quality Assurance: Enhancing Pharmaceutical Product Integrity and Compliance
Abstract: The pharmaceutical industry is undergoing a paradigm shift driven by stringent regulatory expectations and the demand for high-quality, safe, and efficacious drug products. Quality Control (QC) and Quality Assurance (QA) serve as the two foundational pillars that ensure pharmaceutical integrity from raw material acquisition through to product release. Traditional QC and QA practices, while effective, have been challenged by complex formulations, biologics, and personalized medicine, requiring innovative methodologies and technologies. …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 16, Issue 2, 2025 · pp. 54–62 Read article
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Role of Pharmaceutical Software in Vaccine Development and Manufacturing Process Optimization
Abstract: Vaccine development and manufacturing have become increasingly complex due to the emergence of diverse vaccine platforms, stringent regulatory expectations, and global demand for safe and effective immunization. Across the vaccine lifecycle – from antigen design and preclinical evaluation to large‑scale manufacturing and post‑marketing surveillance – pharmaceutical software now plays a central role in handling data, optimizing processes, and ensuring regulatory compliance. Software tools support in silico antigen and epitope design, …
Published in International Journal of Vaccines · Vol. 3, Issue 1, 2026 · pp. 1–8 Read article
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Advancements in Analytical Techniques and Validation Methods for Pharmaceutical Tablet Formulations Using HPTLC
Abstract: High Performance Thin Layer Chromatography (HPTLC) is a versatile analytical technique which has been effectively used for pharmaceutical quality control and cost effectively, rapidly, and high throughput analyzed tablet formulations. HPTLC is different from traditional chromatographic methods as multi sample analysis is possible in one run with low consumption of solvent, which are principles of green analytical chemistry. But existing HPTLC is limited in sensitivity, resolution and reproducibility and these …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 13, Issue 3, 2026 Read article